K Number
K193241
Device Name
Emission Computed Tomography System
Date Cleared
2020-01-26

(62 days)

Product Code
Regulation Number
892.1200
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images. This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.
Device Description
The uMI 550 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy. The uMI 550 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard. The uMI 550 PET/CT has been previously cleared by FDA via K182237. The modifications performed on the uMI 550 PET/CT (K182237) in this submission are due to the addition of HYPER Iterative and Auto-Planbox function. Meanwhile the sensitivity specification has been updated. HYPER Iterative allows more iterations while remains the image noise at an acceptable level by incorporating a noise control term into the objective function. HYPER Iterative can achieve high image contrast and quantification accuracy. Auto-Planbox plan the scan range by recognizing body parts on CT scout image. It locates the different body parts based on anatomy characteristic. The scan range is generated to cover the whole body parts according to protocol selection. This function will simplify scanning process, which will be convenient for user operation.
More Information

Not Found

Yes
The "Auto-Planbox" function, which recognizes body parts on a CT scout image and plans the scan range based on anatomical characteristics, strongly suggests the use of image recognition or computer vision techniques, which are often implemented using AI/ML. While the summary doesn't explicitly use the terms AI or ML, the description of this function aligns with typical AI/ML applications in medical imaging for automation and workflow optimization.

No

This device is described as a "diagnostic imaging system" intended to "assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation," rather than directly treating a disease or disorder.

Yes

The "Intended Use / Indications for Use" section explicitly states that the system is intended to "assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders". These functions are characteristic of a diagnostic device.

No

The device is described as a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner, which is a hardware system. While it includes software for various functions, it is not solely software.

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
  • Device Function: The uMI 550 PET/CT is an imaging system. It uses external energy sources (PET radiopharmaceuticals and X-rays) to create images of the inside of the patient's body. It does not analyze samples taken from the body.
  • Intended Use: The intended use clearly states it's a "diagnostic imaging system" used to "assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders". This is consistent with an imaging device, not an IVD.
  • Device Description: The description details the components of an imaging scanner (PET and CT scanner, patient table, workstation) and the process of image acquisition and reconstruction. It does not mention any components or processes related to analyzing biological samples.

While the device is used for diagnosis, the method of diagnosis is through imaging the body directly, not by analyzing samples in vitro.

No
The provided text does not contain any explicit statement that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.

Intended Use / Indications for Use

The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Product codes

KPS, JAK

Device Description

The uMI 550 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy.

The uMI 550 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.

The uMI 550 PET/CT has been previously cleared by FDA via K182237. The modifications performed on the uMI 550 PET/CT (K182237) in this submission are due to the addition of HYPER Iterative and Auto-Planbox function. Meanwhile the sensitivity specification has been updated. HYPER Iterative allows more iterations while remains the image noise at an acceptable level by incorporating a noise control term into the objective function. HYPER Iterative can achieve high image contrast and quantification accuracy. Auto-Planbox plan the scan range by recognizing body parts on CT scout image. It locates the different body parts based on anatomy characteristic. The scan range is generated to cover the whole body parts according to protocol selection. This function will simplify scanning process, which will be convenient for user operation.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

PET, CT

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

qualified healthcare professionals

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

For HYPER Iterative function, the evaluation and analysis used the identical raw datasets obtained on UIH's uMI 550 system.
For Auto-Planbox function, the evaluation and analysis used 16 group scout images.

Clinical Image Evaluation: The reader study used a total of 20 retrospectively collected clinical cases. The raw data from each of these cases was reconstructed with both OSEM and HYPER Iterative. Each image was read by 3 American board-certified nuclear medicine physicians.

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-Clinical Testing:

  • Electrical Safety and Electromagnetic Compatibility (EMC) testing.
  • Product Particular Standards testing.
  • Performance Verification:
    • NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs.
    • Clinical Image Evaluation for sample clinical images.
    • AEC Test for AEC performance study.
    • Performance Evaluation for HYPER Iterative function.
    • Performance Evaluation for Auto-Planbox function.

Bench testing was performed to support substantial equivalence and the product performance claims.

  • For HYPER Iterative function, the evaluation and analysis used the identical raw datasets obtained on UIH's uMI 550 system and then applied both OSEM and HYPER Iterative. The resultant images were compared for:
    • Quantification accuracy and signal to noise ratio (SNR) using the NEMA IO phantom.
    • Lesion detectability using patient data.
    • Influence of regularization parameter selection using patient data.
    • Effectiveness for large weight patient.
    • Image contrast improvement on brain imaging.
    • Bench testing showed that HYPER Iterative can be used in PET body and brain imaging, can provide the flexibility to achieve user-preferable image by adjusting the regularization parameter, and its images have demonstrated improved image quality, higher quantification accuracy, and improved image SNR than OSEM images.
  • For Auto-Planbox function, the evaluation and analysis used 16 group scout images and compared Auto-Planbox recognition with manual annotation body parts position. Bench testing results showed that Auto-Planbox can locate head center position, body start position and body end position with proper accuracy and can assist operator to plan the scan range.

Clinical Image Evaluation:

  • Study type: Reader study (20 retrospectively collected clinical cases).
  • Image assessment metrics: image contrast according to 3-point scale ("+" represents better contrast image for small lesion detection; "-"represents worse contrast image for small lesion detection; "="represents similar contrast image for small lesion detection), and image quality according to a 5-point scale (1= images are unreadable and cannot be used for diagnosis, 2=insufficient image quality and may affect diagnosis; 3=image quality is barely ok for diagnosis; 4=image quality is sufficient for diagnosis; 5=wonderful image quality for diagnosis).
  • Key results: The results of the study indicated that HYPER Iterative has better image contrast than OSEM and the image quality is sufficient for clinical diagnosis.

No Clinical Study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

  • Sensitivity: >/=9cps/kBq @0cm, >/=9cps/kBq @10cm (Current device); >/=10cps/kBq @0cm, >/=10cps/kBq @10cm (Predicate device).
  • NECR Peak Value: >/=90 kcps@13kBq/cc
  • Peak True Count Rate: >/=300kcps@27kBq/cc
  • PET Scatter Fraction: =45.0%, 13 mm >=55.0%, 17 mm >=65.0%, 22 mm >=72.0%, 28 mm >=65.0%, 37 mm >=70.0%
  • Image Quality Background variability: 10 mm

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.

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Shanghai United Imaging Healthcare Co., Ltd % Shumei Wang QM & RA VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 CHINA

January 26, 2020

Re: K193241

Trade/Device Name: uMI 550 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: November 22, 2019 Received: November 25, 2019

Dear Shumei Wang:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193241

Device Name uMI 550

Indications for Use (Describe)

The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Type of Use (Select one or both, as applicable)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) SUMMARY

    1. Date of Preparation: January 22, 2020

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com

3. Identification of Proposed Device

Trade Name: uMI 550 Common Name: Emission Computed Tomography System

Model(s): uMI 550

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

4. Identification of Predicate Device(s)

Predicate Device

510(k) Number: K182237 Device Name: uMI 550 Model(s): uMI 550

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

5. Device Description

The uMI 550 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended

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to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy.

The uMI 550 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.

The uMI 550 PET/CT has been previously cleared by FDA via K182237. The modifications performed on the uMI 550 PET/CT (K182237) in this submission are due to the addition of HYPER Iterative and Auto-Planbox function. Meanwhile the sensitivity specification has been updated. HYPER Iterative allows more iterations while remains the image noise at an acceptable level by incorporating a noise control term into the objective function. HYPER Iterative can achieve high image contrast and quantification accuracy. Auto-Planbox plan the scan range by recognizing body parts on CT scout image. It locates the different body parts based on anatomy characteristic. The scan range is generated to cover the whole body parts according to protocol selection. This function will simplify scanning process, which will be convenient for user operation.

The modifications are listed as follow:

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Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized, dark teal-colored symbol that resembles a shield with a white line running horizontally through the center. The logo is simple and modern, conveying a sense of strength and innovation.

  • Introduce HYPER Iterative function. >
  • Introduce Auto-Planbox function.

  • Update sensitivity specification.

| | uMI 550 PET/CT
previous
submission(K182237) | uMI 550 PET/CT this
submission | Remark |
|--------------------|---------------------------------------------------|---------------------------------------|------------------------------------------------|
| Sensitivity | >/=10cps/kBq @0cm

/=10cps/kBq @10cm | >/=9cps/kBq @0cm
/=9cps/kBq @10cm | Sensitivity specification
has been updated. |
| HYPER
Iterative | Not available | Available | New function has been
added |
| Auto-
Planbox | Not available | Available | New function has been
added |

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6. Indications for Use

The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

7. Comparison of Technological Characteristics with the Predicate Devices

The technology characteristics of the modified uMI 550. reflected in this 510(k) submission, do not alter the scientific technology of the devices and are substantially equivalent to those of the predicate devices.

Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.

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| ITEM | Table 1 Comparison of Technological Characteristics
Proposed Device
uMI 550 | Predicated Device
uMI 550(K182237) | Remark | | |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------|------------------------|-------|
| General | | | | | |
| Product Code | KPS, JAK | KPS, JAK | Same | | |
| Regulation No. | 21 CFR 892.1200 | 21 CFR 892.1200 | Same | | |
| Class | Class II | Class II | Same | | |
| Intended Use | The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.
This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and | The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.
This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and | Same | | |
| Specifications | | | | | |
| PET Specifications | | | | | |
| Scintillator material | LYSO | LYSO | Same | | |
| Scintillator dimensions | 2.76mm×2.76mm×16.3mm | 2.76mm×2.76mm×16.3mm | Same | | |
| Number of detector rings | 84 | 84 | Same | | |
| Number of image planes | 167 | 167 | Same | | |
| Axial field of view | 24cm | 24cm | Same | | |
| Image matrix sizes | 128×128, 150×150, 192×192, 256×256, 512×512, 600×600 | 128×128, 150×150, 192×192, 256×256, 512×512, 600×600 | Same | | |
| Coincidence window | 4.0ns | 4.0ns | Same | | |
| Spatial Resolution | Axial FWHM@1 cm | /=9cps/kBq | >/=10cps/kBq | Note No.1 | | |
| NECR Peak Value | >/=90 kcps@13kBq/cc | >/=90 kcps@13kBq/cc | Same | | |
| Peak True Count Rate | >/=300kcps@27kBq/cc | >/=300kcps@27kBq/cc | Same | | |
| PET Scatter Fraction | =45.0% | | =55.0% | | =65.0% | | NEMA XR 29-2013: Standard Attributes on CT Equipment Related to Dose Optimization and Management

Performance Verification

  • A NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs
  • Clinical Image Evaluation for sample clinical images

  • A AEC Test for AEC performance study
  • A Performance Evaluation for HYPER Iterative function
  • A Performance Evaluation for Auto-Planbox function

Bench testing was performed to support substantial equivalence and the product performance claims. For HYPER Iterative function, the evaluation and analysis used the identical raw datasets obtained on UIH's uMI 550 system and then applied both OSEM and HYPER Iterative. The resultant images were compared for:

  • Ouantification accuracy and signal to noise ratio (SNR) using the NEMA IO phantom
  • Lesion detectability using patient data
  • Influence of regularization parameter selection using patient data
  • Effectiveness for large weight patient
  • Image contrast improvement on brain imaging

Bench testing showed that HYPER Iterative can be used in PET body and brain imaging, can provide the flexibility to achieve user-preferable image by adjusting the regularization parameter, and its images have demonstrated improved image quality, higher quantification accuracy, and improved image SNR than OSEM images.

For Auto-Planbox function, the evaluation and analysis used 16 group scout images and compared Auto-Planbox recognition with manual annotation body parts position. Bench testing results showed that Auto-Planbox can locate head center position, body

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start position and body end position with proper accuracy and can assist operator to plan the scan range.

Software

  • NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
  • A IEC 62304: Medical Device Software - software life cycle process
  • Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices

  • A Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Biocompatibility

  • ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices A - Part 10: Tests for irritation and skin sensitization
  • A ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

Other Standards and Guidances

  • ISO 14971: Medical Devices Application of risk management to medical A devices
  • Code of Federal Regulations, Title 21, Part 820 Quality System Regulation A
  • Code of Federal Regulations, Title 21, Subchapter J Radiological Health A
  • A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
  • A Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.

The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.

UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

Clinical Image Evaluation

The reader study used a total of 20 retrospectively collected clinical cases. The raw data from each of these cases was reconstructed with both OSEM and HYPER Iterative. Each image was read by 3 American board-certified nuclear medicine

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physicians who provided an assessment of image contrast according to 3-point scale ("+" represents better contrast image for small lesion detection; "-"represents worse contrast image for small lesion detection; "="represents similar contrast image for small lesion detection), and image quality according to a 5-point scale (1= images are unreadable and cannot be used for diagnosis, 2=insufficient image quality and may affect diagnosis; 3=image quality is barely ok for diagnosis; 4=image quality is sufficient for diagnosis; 5=wonderful image quality for diagnosis). The results of the study indicated that HYPER Iterative has better image contrast than OSEM and the image quality is sufficient for clinical diagnosis.

Clinical Testing

No Clinical Study is included in this submission.

9. Conclusions

Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device.